Generic drugmaker Mylan Pharmaceuticals Inc. has received FDA approval to begin shipping a generic version of a drug that treats gallstones.
Ursodial USP is the generic version of Watson Pharmaceuticals’ Actigall capsules. A number of other drugmakers sell Ursodial capsules, including Lannett Company and Teva Pharmaceuticals.
Ursodia USP is a bile acid that naturally occurs in the body. In capsule form, it helps to dissolve gallstones, hardened deposits of digestive fluid that form in the gallbladder. The cause of gallstones is unclear, but one factor could be an excess amount of cholesterol in a patient’s bile.
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Ursodial capsules had U.S. sales of $30 million last year, according to a statement from Mylan.
Actigall was introduced in the U.S. in 1988. Watson acquired its U.S. rights for an undisclosed amount from Novartis Pharmaceuticals Corp. in 2002.
Mylan reported more than $5 billion in revenues last year, about the same as the prior year. Profits stood at $94 million, up from a loss the prior year.
The company made a big acquisition in 2007, when it paid $6.8 billion to acquire Merck Generics, a deal that doubled Mylan’s size.
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